Biktarvy is specifically indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

Biktarvy is supplied as a tablet for oral administration. The recommended dose is one tablet once daily with or without food.

Clinical Results

FDA Approval

The FDA approval of Biktarvy was based on four Phase III studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.

In Study 1489: a total of 629 treatment-naïve adults with HIV were randomized 1:1 to receive Biktarvy or abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC). At Week 48, 92.4% (n=290/314) of patients taking Biktarvy and 93% of patients taking ABC/DTG/3TC achieved the primary endpoint of HIV-1 RNA <50 c/mL. In Study 1490, a total of 645 treatment-naïve adults with HIV were randomized 1:1 to receive Biktarvy or DTG+FTC/TAF. At Week 48, 89.4% n=286/320) of patients taking Biktarvy and 92.9% (n=302/325) of patients taking DTG+FTC/TAF achieved the primary endpoint of HIV-1 RNA <50 c/mL.

In Study 1878, a total of 577 virologically suppressed (HIV-1 RNA <50 c/mL) adults with HIV taking regimens of a boosted protease inhibitor (bPI; atazanavir or darunavir) plus a dual-NRTI backbone (ABC/3TC or FTC/tenofovir disoproxil fumarate) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated Biktarvy once daily. At the primary endpoint of Week 48, switching to Biktarvy was non-inferior to continuing on a bPI regimen with 1.7 percent of patients in each group having HIV-1 RNA ≥50 c/mL; the proportion of patients with HIV-1 RNA <50 c/mL was 92.1% in the Biktarvy arm and 88.9% in the bPI arm, according to FDA snapshot algorithm. Results from Study1844 were planned for presentation at a scientific conference in 2018.

Side Effects

Adverse events associated with the use of Biktarvy may include, but are not limited to, the following:

diarrhea

nausea

headache

The Biktarvy drug label comes with the following Black Box Warning:

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Biktarvy. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted.